贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.97 3036833045293041033041713044933041960.12
29.963038283039333038800.03
单位质量响应值RSD%判断
30511.1330510.040.01数据可信
供试品溶液-24061701批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192056-9205630.08728.966.6630.0928.966.66
281134-8113426.51826.52
394155-9415530.77330.77
494611-9461130.92230.92
587244-8724428.51528.51
682475-8247526.95626.96
10min1203258-20325866.43265.791.2666.7766.121.27
2202785-20278566.27866.57
3202480-20248066.17866.52
4201428-20142865.83466.18
5201484-20148465.85366.17
6196382-19638264.18564.48
15min1233666-23366676.37175.800.8177.4476.850.80
2234134-23413476.52477.55
3230504-23050475.33776.41
4230431-23043175.31376.39
5232916-23291676.12677.17
6229868-22986875.12976.14
20min1249203-24920381.44980.960.8283.3782.860.80
2250212-25021281.77983.66
3245971-24597180.39382.31
4245782-24578280.33182.24
5249127-24912781.42483.32
6246007-24600780.40482.25
30min1267382-26738287.39087.530.7590.2290.320.72
2271082-27108288.60091.39
3265870-26587086.89689.70
4265751-26575186.85789.66
5268844-26884487.86890.67
6267899-26789987.55990.30
45min1283049-28304992.51193.200.6096.3196.970.55
2285816-28581693.41597.19
3283909-28390992.79296.57
4284177-28417792.88096.65
5286950-28695093.78697.56
6287080-28708093.82897.54
60min1291442-29144295.25496.270.73100.08101.080.68
2294188-29418896.152100.96
3293758-29375896.011100.82
4294132-29413296.133100.93
5296183-29618396.804101.62
6297653-29765397.284102.04
极限1297101-29710197.10498.110.82102.99103.980.76
2300185-30018598.112103.99
3300161-30016198.104103.97
4298781-29878197.653103.52
5300433-30043398.193104.09
6304436-30443699.501105.34
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.97 3035033033993039823037583031793035640.11
29.963031183032453031820.03
单位质量响应值RSD%判断
30447.7430439.960.02数据可信
供试品溶液-24061702批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177139-7713925.26728.878.7325.2728.878.73
2100060-10006032.77532.78
385377-8537727.96627.97
486178-8617828.22828.23
587344-8734428.61028.61
692692-9269230.36230.36
10min1193136-19313663.26266.323.5163.5466.643.54
2212264-21226469.52869.89
3203616-20361666.69567.01
4203092-20309266.52466.84
5195652-19565264.08764.40
6207072-20707267.82768.16
15min1233927-23392776.62478.162.1377.6179.222.15
2244269-24426980.01181.15
3240864-24086478.89679.95
4240532-24053278.78779.84
5230928-23092875.64176.67
6241150-24115078.99080.08
20min1253645-25364583.08283.901.4484.9285.831.47
2259931-25993185.14187.17
3257966-25796684.49886.43
4257889-25788984.47386.40
5249945-24994581.87083.74
6257555-25755584.36386.33
30min1275511-27551190.24590.540.8993.0093.400.92
2277916-27791691.03294.00
3277062-27706290.75393.62
4279077-27907791.41394.28
5272060-27206089.11491.89
6276863-27686390.68893.59
45min1293990-29399096.29895.980.61100.0699.850.54
2291702-29170295.54899.53
3291884-29188495.60899.48
4295329-29532996.736100.62
5294384-29438496.427100.20
6290902-29090295.28699.20
60min1303851-30385199.52898.610.88104.36103.540.78
2298152-29815297.661102.71
3299549-29954998.118103.06
4303519-30351999.419104.38
5302744-30274499.165104.01
6298419-29841997.748102.72
极限1308824-308824101.15699.921.20107.09105.941.08
2301756-30175698.841104.97
3303263-30326399.335105.36
4307393-307393100.688106.75
5308512-308512101.054107.00
6300510-30051098.433104.49
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.97 3034373035193041663033963039613036960.12
29.963037313028623032960.21
单位质量响应值RSD%判断
30460.9830451.410.03数据可信
供试品溶液-24061701批-pH4.5(内含0.45%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121253-212536.9598.1510.636.968.1510.62
226648-266488.7258.73
327091-270918.8708.87
425033-250338.1968.20
522049-220497.2197.22
627278-272788.9318.93
10min161501-6150120.13720.962.7920.2121.052.83
265717-6571721.51721.61
365076-6507621.30721.41
463634-6363420.83520.93
562389-6238920.42720.51
665685-6568521.50721.61
15min178908-7890825.83626.081.9226.1426.411.95
279455-7945526.01526.35
381036-8103626.53326.87
478472-7847225.69326.02
578142-7814225.58525.89
681998-8199826.84827.19
20min186608-8660828.35728.591.5928.9529.201.60
288306-8830628.91329.54
389517-8951729.31029.94
487149-8714928.53429.14
585665-8566528.04928.64
686640-8664028.36829.00
30min197447-9744731.90631.952.8032.8132.882.77
299267-9926732.50233.45
3101120-10112033.10934.06
493179-9317930.50931.43
596180-9618031.49132.39
698349-9834932.20233.15
45min1104257-10425734.13634.391.6035.3935.681.60
2107005-10700535.03636.34
3107364-10736435.15336.48
4103922-10392234.02635.29
5104105-10410534.08635.34
6103635-10363533.93235.24
60min1111373-11137336.46636.441.3238.1038.111.34
2112972-11297236.98938.69
3112787-11278736.92938.64
4109090-10909035.71837.36
5110413-11041336.15237.78
6111146-11114636.39238.08
极限1118653-11865338.84938.471.7040.8940.541.67
2118820-11882038.90441.01
3119935-11993539.26941.39
4117025-11702538.31640.36
5114663-11466337.54339.58
6115888-11588837.94440.04
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.97 3035013033063030523033583032863033010.06
29.963031073036223033640.13
单位质量响应值RSD%判断
30421.3630458.230.09数据可信
供试品溶液-24061702批-pH4.5(内含0.45%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121867-218677.1646.707.227.166.707.22
219181-191816.2846.28
320927-209276.8566.86
422420-224207.3457.34
519239-192396.3036.30
619139-191396.2706.27
10min158057-5805719.01918.746.9019.1018.826.89
258693-5869319.22819.30
359024-5902419.33619.41
462205-6220520.37820.46
551125-5112516.74816.82
654118-5411817.72917.80
15min177100-7710025.25825.334.5625.5525.624.55
282594-8259427.05827.34
375088-7508824.59924.89
479766-7976626.13126.44
572510-7251023.75424.01
676915-7691525.19725.46
20min185570-8557028.03328.143.4828.6028.703.50
288663-8866329.04629.63
386569-8656928.36028.92
489551-8955129.33729.94
582573-8257327.05127.57
682457-8245727.01327.56
30min1102244-10224433.49532.473.8334.3833.353.83
2101734-10173433.32834.23
398249-9824932.18633.07
4102710-10271033.64834.57
593211-9321130.53631.36
696557-9655731.63232.48
45min1111149-11114936.41235.672.7637.6736.902.78
2113085-11308537.04638.32
3108713-10871335.61436.85
4108437-10843735.52436.82
5104402-10440234.20235.36
6107450-10745035.20036.40
60min1114898-11489837.64037.781.8639.3039.411.89
2117518-11751838.49940.19
3117585-11758538.52140.15
4115978-11597837.99439.69
5113757-11375737.26738.81
6112174-11217436.74838.34
极限1125541-12554141.12739.972.3343.2042.022.25
2124343-12434340.73442.85
3120711-12071139.54541.61
4120416-12041639.44841.56
5123100-12310040.32742.28
6117913-11791338.62840.63
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